[Federal Register Volume 75, Number 165 (Thursday, August 26, 2010)]
[Notices]
[Pages 52533-52534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21220]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995. To request more
information on the proposed project or to obtain a copy of the data
collection plans and draft instruments, e-mail [email protected] or
call the HRSA Reports Clearance Officer at (301) 443-1129.
Comments are invited on: (a) The proposed collection of information
for the proper performance of the functions of the agency; (b) the
accuracy of the agency's estimate of the burden of the proposed
collection of information; (c) ways to enhance the quality, utility,
and clarity of the information to be collected; and (d) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology.
[[Page 52534]]
Proposed Project: Sickle Cell Disease and Other Hemoglobinopathies
Program Evaluation--[NEW]
Background: In response to the growing need for resources devoted
to sickle cell disease and other hemoglobinopathies, Congress, under
Section 501(a)2 of the Social Security Act (2000), authorized the
appropriation of funds for enabling the Secretary to provide for
special projects of regional and national significance, research and
training with respect to maternal and child health and children with
special health care needs the following: Genetic disease testing,
counseling and information development and dissemination programs, for
grants relating to hemophilia without regard to age, and for the
screening of newborns for sickle cell anemia and other genetic
disorders, and follow-up services. As stated in House Report No. 107-
229 regarding the Department of Labor, Health and Human Services, and
Education, and Related Agencies Appropriation Bill 2002, the purpose of
the Sickle Cell Disease and Newborn Screening Program (SCDNBSP) is ``to
enhance the sickle cell disease newborn screening program and its
locally based outreach and counseling efforts.'' In addition, the
American Jobs Creation Act of 2004, Public Law 108-357, states that ``*
* * the Bureau of Primary Health Care and the Maternal and Child Health
Bureau, shall conduct a demonstration program by making grants for up
to 40 eligible entities, for each fiscal year in which the program is
conducted under this section, for the purpose of developing and
establishing systemic mechanisms to improve the prevention and
treatment of Sickle Cell Disease.'' (See 42 U.S.C. 300b-1).
Purpose: HRSA's activities under the legislative authorities
relative to the Sickle Cell Disease and Newborn Screening Program
(SCDNBSP) have been delegated to the Maternal and Child Health Bureau
(MCHB), Genetic Services Branch (GSB). The MCHB's GSB supports
seventeen community based organizations and the National Coordinating
and Evaluation Center for the Sickle Cell Disease and Newborn Screening
Program (SCDNBS) in addition to nine cooperative agreements and a
National Coordinating Center for the Sickle Cell Disease Treatment
Demonstration Program (SCDTDP). An evaluation will be conducted to
assess the service delivery processes and quality of the system of care
delivered by grantees under the Newborn Screening Program to
individuals affected by Sickle Cell disease who present at their sites
for care. The Centers for Disease Control and Prevention defines
Hemoglobinopathies as ``a group of disorders affecting red blood cells.
SCD and Thalassemia are included in this group.'' (See http://www.cdc.gov/ncbddd/sicklecell/RuSH_FAQs.html). The information from
the evaluation will be used to evaluate the grantees' performance in
achieving the objectives of the hemoglobinopathies program during the
grant period, assess the breadth of grantees' outreach to emerging
populations affected by hemoglobinopathies and the needs of those
populations attempting to access services. Data collection tools for
which OMB approval is being requested are as follows: (1) The Minimum
Database Project Sickle Cell Disease (MDP SCD) Questionnaire, (2) the
Minimum Database Project Sickle Cell Trait/Carrier (MDP SCT)
Questionnaire, and (3) the MDP Hemoglobinopathies Emerging Populations
Questionnaire.
Respondents: The MDP SCD and the MDP SCT Questionnaires will be
administered by grantees to clients or caregivers when they present for
services. At the time of enrollment, SCDNBSP participants will be
informed about the data collection and clients will be asked to
participate in either the SCD questionnaire or the SCT questionnaire
depending on their disease or carrier status. The program will enroll
participants on a rolling basis such that new patients will be added to
the program as they present for services and provide consent. Data will
be collected at two points annually for the SCD Questionnaire, the
first, when clients and caregivers are enrolled into the SCDNBS Program
and the second, at follow-up after enrollment. Data will be collected
once annually for the SCT Questionnaire. The Hemoglobinopathies
Emerging Populations Form serves as a stand alone form for the other
HRSA hemoglobinopathies programs, with its content. These questions are
also embedded in the MDT SCD and MDP SCT questionnaires. The HRSA
hemoglobinopathies programs also plan to use this questionnaire in
developing educational materials, prioritizing outreach activities and
informing decisions for future funding requests.
The annual estimate of burden is as follows:
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Number of Responses per Total Average hours Total hour Total hour
Questionnaires respondents respondent responses per response burden Wage rate cost
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MDP SCD Questionnaire............................ 140 2 280 .45 126 $20.90 $2,633.40
MDP SCT Questionnaire............................ 1,400 1 1,400 .30 420 20.90 8,778.00
Hemoglobinopathies Emerging Populations Form..... *1,125 2 *2,250 .20 450 20.90 9,405.00
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Total........................................ 2,665 .............. 3,930 .............. 996 ........... 20,816.40
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E-mail comments to [email protected] or mail the HRSA Reports
Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments should be received within 60 days
of this notice.
Dated: August 19, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information Coordination.
[FR Doc. 2010-21220 Filed 8-25-10; 8:45 am]
BILLING CODE 4165-15-P